For over 25 years, Malcom Associates consultants have provided solutions to the Pharmaceutical, Biologics, Medical Device, and Nutraceutical industries. We have implemented consulting solutions for our clients such as: • Process and data work flow improvement and batch record documentation redesign solutions • Develop Guidance Document for documentation industry ‘best practices’ • Implementing robust risk-based investigation process • SOP simplification and authoring guidelines (production, equipment cleaning, etc.) • Framework for efficient 510k process • Improve ISO 14791 compliance • Core Competency Development • 3rd Party Investigations • Value Stream mapping Malcom’s industry ‘best practice ‘ solutions reduce human errors and redundancies, improve work flows, data integrity, regulatory and remediation compliance, documentation and procedural practices, product release cycle times, reduces training time, speed to market, and more. Malcom’s projects are cost-effective and result in high return on investment for our clients. EBR/MES Deployment Malcom’s batch record redesign methodology is the first step for automating your manufacturing and documentation related processes. That is why Malcom Associates partners with software vendors to ensure our clients data, work flow, integration requirements and automation benefits are optimized. This reduces the implementation time, resource requirements, and investment.